Packaging system for transdermal drug delivery systems

Abstract

A device and method for stabilizing a drug, particularly a chiral drug or the active enantiomer(s) thereof, in a carrier composition of a transdermal delivery system prior to the systems use by providing a product packaging system to prevent or control degradation reactions that can result from certain packaging materials and moisture contamination, while at the same time providing a child-resistant wrapping for the transdermal system.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims the benefit of U.S. Provisional Application Ser. No. 60 / 285,976 filed Apr. 23, 2001, and is a continuation-in-part of U.S. patent application Ser. No. 09 / 804,926 filed on Mar. 13, 2001, abandoned, which claims the benefit of U.S. Provisional Application Ser. No. 60 / 189,333 filed Mar. 14, 2000, which are expressly incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to stabilizing a drug in a packaged product. More specifically, the present invention relates to a packaging system for the prevention of degradation in pharmaceutical products, particularly controlled release drug delivery devices such as transdermal systems.[0004]2. Description of Related Art[0005]The use of transdermal drug delivery systems or “patches” as a means to topically administer a drug is well known. Such systems dissolve or disperse the drug into a ca...

AI Technical Summary

Benefits of technology

[0025]The foregoing and other objects are achieved with this invention by providing a pouch for a transdermal system that is inert to the components of the transdermal system, water vapor permeable to permit removal of moisture from within the pouch, and child-resistant. The pouched transdermal system is further sealed within a substantially

Problems solved by technology

Moreover, certain isomers may actually be deleterious rather than simply inactive or inert.

For example, U.S. Pat. No. 5,008,110 discloses that certain polyolefin materials used for transdermal devices tend to absorb lipophilic solvents and/or enhancers, which can significantly decrease the drug's solubility in the carrier composition, as well as cause physical failure of the packaging material.

U.S. Pat. No. 4,943,435 discloses that nicotine will adversely affect many common transdermal system component materials such as adhesives, membranes, backings and release liners.

It has been additionally discovered that methylphenidate, a chiral drug that exists as four enantiomers of which only one is currently known to be significantly pharmacodynamically active, is unstable in the presence of certain types of packaging materials used for transdermal systems.

It is further known that common environmental factors such as the presence of water (in liquid or vapor form), air and light can adversely affect the stability of some drugs.

Such environmental factors can further affect the solubility of the drug in the carrier composition, which in turn can also significantly impact the shelf-life of the transdermal system.

As a result, packaging materials produced of multiple layers, many incorporating metal foils, are typically required to provide an environmental barrier.

Such packaging requirements often result in higher cost

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